Federal Safety Regulation on Medical Devices Preempts Tort Claims

Abstract:     
In Riegel v. Medtronic Inc. (552 U.S._2008; February 20, 2008), Mr. Riegel underwent emergency coronary bypass surgery because of during the practice of a coronary angioplasty the catheter manufactured by Medtronic ruptured. Although the catheter had been approved by FDA and complied with federal safety requirements, Mr. Riegel and his wife brought an action against Medtronic - and not against the doctor - on the basis of New York Common Law causes of action for negligence and strict liability. However, a majority of Supreme Court justices of the United States, through an opinion delivered by Justice Antonin Gregory Scalia) affirmed the judgment of the Court of Appeals and hold that Medical Device Amendment of 1976's preemption clause [21 U.S.C. Sec. 360k(a)] bars not only state regulatory law, but also state Common Law claims of strict liability and negligence.

Keywords: Product Safety, Product Liability, Regulatory Compliance, Pharmaceutical Law, Health Law

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